NL-OMON54622招募中3 期
A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinituzumab (GA101) plus venetoclax (GVe) versus obinituzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without Del (17p) or TP53 mutation. - CLL13 / HO140
niversity of Cologne0 个研究点目标入组 185 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Documented CLL requiring treatment according to iwCLL criteria.
- •-Age at least 18 years.
- •-Life expectancy >= 6 months.
- •-Ability and willingness to provide written informed consent and to adhere to
- •the study visit
- •schedule and other protocol requirements.
- •-Adequate bone marrow function indicated by a platelet count >30 x10^9/l
- •(unless directly
- •attributable to CLL infiltration of the bone marrow proven by bone marrow
- •-GFR >=70ml/min directly measured with 24hr urine collection or calculated
- •according to the modified formula of Cockcroft and Gault (for men: GFR * ((140
- •bodyweight) / (72 x creatinine), for women x 0, 85) or an equally accurate
- •method. For patients with creatinine values within the normal range the
- •calculation of the clearance is not necessary. Dehydrated patients with an
- •estimated creatinine clearance less than 70 ml/min may be eligible if a repeat
- •estimate after adequate hydration is > 70 ml/min.
- •-Adequate liver function as indicated by a total bilirubin<= 2 x, AST/ALT <= 2.5
- •x the institutional
- •ULN value, unless directly attributable to the patient*s CLL or to Gilbert*s
- •-Negative serological testing for hepatitis B (HBsAg negative and anti-HBc
- •negative; patients
- •positive for anti-HBc may be included if PCR for HBV DNA is negative and HBVDNA
- •PCR is performed every month until 12 months after the last treatment cycle),
- •testing for hepatitis C RNA within 6 weeks prior to registration.
- •-Eastern Cooperative Oncology Group Performance Status (ECOG) performance
排除标准
- •-Any prior CLL-specific therapies (except for corticoid treatment administered
- •due to necessary
- •immediate intervention; within the last 10 days before start of study treatment
- •equivalents up to 20 mg prednisolone are permitted).
- •-Transformation of CLL (Richter*s transformation).
- •-Decompensated hemolysis, defined as ongoing hemoglobin drop in spite of
- •prednisolone or intravenous immunoglobulins (IVIG). Prior treatment with
- •rituximab even for other indications than CLL is not permitted.
- •-Detected del(17p) or TP53 mutation.
- •-Patients with a history of confirmed PML.
- •-Any comorbidity or organ system impairment rated with a single CIRS
- •(cumulative illness rating
- •scale) score of 4, (excluding the eyes/ears/nose/throat/larynx organ system), a
- •score of more than 6 or any other life-threatening illness, medical condition
- •or organ system
- •dysfunction that - in the investigator*s opinion could compromise the patients
- •safety or interfere
- •with the absorption or metabolism of the study drugs (e.g, inability to swallow
- •tablets or impaired
- •resorption in the gastrointestinal tract).
- •-Urinary outflow obstruction.
- •-Malignancies other than CLL currently requiring systemic therapies, not being
- •treated in curative
- •intention before (unless the malignant disease is in a stable remission due to
- •the discretion
- •of the treating physician) or showing signs of progression after curative
- •-Uncontrolled or active infection.
- •-Patients with known infection with human immunodeficiency virus (HIV).
- •-Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/inducers.
- •-Anticoagulant therapy with warfarin or phenoprocoumon,(rotation to alternative
- •anticoagulation is allowed, but note that patients being treated with NOAKs can
- •be included, but must be properly informed about the potential risk of bleeding
- •under treatment with ibrutinib).
- •-History of stroke or intracranial hemorrhage within 6 months prior to
- •randomization.
- •-Use of investigational agents which might interfere with the study drug within
- •28 days prior to
- •registration.
- •-Vaccination with live vaccines 28 days prior to registration.
- •-Major surgery less than 30 days before start of treatment.
- •-History of severe allergic or anaphylactic reactions to humanized or murine
- •monoclonal antibodies,
- •known sensitivity or allergy to murine products.
- •-Known hypersensitivity to any active substance or to any of the excipients of
- •one of the drugs
- •used in the trial.
- •-Pregnant women and nursing mothers (a negative pregnancy test is required for
- •all women of
- •childbearing potential within 7 days before start of treatment; further
- •pregnancy testing will be
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